NCT01536314已完成3 期
Preventing the Development of Neuropathic Pain Post-mastectomy/Tumorectomy by Pre-emptive or Post-operative Memantine Administration
University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2012年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- average painful intensity
研究概览
简要总结
The aim of this study is to evaluate if memantine administered during 4 weeks beginning 2 weeks before surgery induces a decrease of painful intensity 3 months after surgery, compared to placebo group.
详细描述
The aim of this study is to evaluate if memantine administered during 4 weeks beginning 2 weeks before surgery induces a decrease of painful intensity 3 months after surgery, compared to placebo group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years old
- •patient suffering breast cancer with mastectomy/tumorectomy with or within cleaning 2 weeks after inclusion with or within pre-emptive chemotherapy
排除标准
- •Against-indication at memantine administration : hypersensitivity at active substance or excipients, hypertension, antecedent cerebrovascular accident, severe cardiac insufficiency
- •Diabetic patient (Type I and II)
- •Patient with medical or surgical antecedents
- •Patient receiving treatment with amantadine, ketamine, dextrometorphan, L-Dopa, dopaminergic, anticholinergic agonists, barbiturate, neuroleptic, IMAO, antispastic agents, dantrolen or baclofen, phenitoin, cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine, hydrochlorothiazide, warfarine
- •Patient with alcohol addiction
- •Woman in childbearing age not using effective contraceptive method, pregnant or lactating woman
- •Patient who participated in another clinical trial, located in exclusion period or received benefits > 4500 euros during 12 months before the beginning of trial
结局指标
主要结局
average painful intensity
时间窗: 5 days before visit of 3 months
次要结局
- Average painful(on 5 days before visit of 6 months post-surgery)
- Evaluation of pain by numerical scale(during 15 first days following surgery and to visit of 3 months)
- analgesic consumption(during 3 months after surgery)
研究者
研究点 (2)
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